1. Field of the Invention
This invention relates in general to a process and device for penile tumescence monitoring and, more particularly, to a device which will allow for small changes in penile circumference to be recorded on magnetic tape.
2. Description of the Prior Art
Penile tumescence monitoring is done for the purpose of medically determining whether male impotence is primarily due to physiological or psychological reasons. The monitoring involves the monitoring of the circumference of the patient's penis while he is asleep so as to determine whether the patient achieves an erection. It has been previously shown that erections will normally occur during the alpha rhythm portion of rapid eye movement portion of sleep. This monitoring aids the doctor in determining the etiology of the patient's impotence. If the patient is impotent because of physiological reasons, he will not achieve an erection while he is asleep. If the patient is impotent because of primarily psychological reasons, he will most likely achieve an erection while he is asleep. Therefore, in the situations where the patient's impotence is caused because of psychological reasons as opposed to physiological reasons a penile tumescence monitoring study may save the patient from undergoing an unnecessary operation, and hopefully encourage him to seek psychiatric counseling.
In the prior art, the penile tumescence monitors that were used tended to be large, bulky, expensive, and complicated. This meant that when a patient underwent a penile tumescence monitoring study he often had to be admitted to the hospital and spend several days there. The prior art basically used devices which used penile tumescence sensors which were attached to the patient's penis. These sensors then sent signals to a large chart recorder device which monitored the patient's penile tumescence during the evening while he slept. The fact that the patient had to check in at the hospital for the purpose of this study made the test expensive for the patient. Further the patient had to undergo a loss of privacy and in some cases much embarrassment.
Unlike the prior art, the present invention provides for a penile tumescence monitoring process and device which is small, compact, reliable and relatively inexpensive. Because the present invention is portable and easy to use the patient can take the monitor home with him and use it in the privacy of his own home while he is asleep. Thus, the patient saves the expense of a hospital stay and is assured privacy and avoids embarrassment.
The patient, in the privacy of his own home, can easily attach the sensors of the small system before he goes to sleep. The small system makes a tape recording of the patient's penile tumescence. The patient then takes this tape recording to the doctor the next day. The doctor can then play back the recording on any suitable display device, for example a large chart recorder, and from this the doctor can determine whether the patient achieved an erection while he was asleep the previous evening. Further, because it is a magnetic tape recording the doctor can alter the gain and frequency of the output so that he can easily create charts whch are easy to read and informative. In the prior art, the doctor had to work with the written chart that had been produced and if it was difficult to discern he would have to rerun the test. With a magnetic tape recording the doctor can make many charts with various resolutions without having to rerun the test and cause concern and embarrassment for the patient.
The following are examples of tumescence monitors that are found in the prior art and that are presently on the market. The Browne Corporation 7600 is a wall plug in model which records penile tumescence by use of a heat stylus on thermal-sensitive and pressure-sensitive chart paper. The Event Systems PTM-1 tumescence monitor is a battery operated device which records the tumescence by use of an impact styli on pressure sensitive chart paper. This device employs two separate styli for base and tip penile tumescence recording. The Farrall Instruments SP-30N tumescence monitor is a battery operated device which records by heat stylus on thermal sensitive chart paper. The Medical Monitoring Systems PRS-102 device is a wall plug in unit which records penile tumescence by heat styli on thermal sensitive Z-fold chart paper. It has two separate channels and styli. All of these devices tend to be expensive and fairly complicated. Further, unlike the present invention, these prior art devices have more that can go wrong with them in operation during a penile tumescence monitoring. The use of chart paper and styli can result in graphs which are difficult to read. The paper can snag. The use of heat sensitive paper and styli can result in problems if there are some variations in heat or otherwise and in general these devices tend to be less reliable and if they break down during the night when the patient is sleeping this means that the patient has to rerun the test. The present invention employs simple magnetic tape recording which is more trouble free than the chart recorders of the prior art.
These prior art devices also present the problem that if the chart recorder's graph is not easily read by the doctor the next day the patient must rerun the test so that a new chart can be made. The magnetic tape recording of the present invention is also superior because it allows the doctor to create a readable chart by playing back the magnetic tape recording. He can create charts which are easy to read by simply altering the gain and the frequency of the output. Therefore the patient does not need to rerun the test for the doctor to have a readable chart.
All of these devices use more than one strain gauge and therefore must record simultaneously the signals from the various strain gauges. The chart recorders record the signals in the various strain gauges through the use of more than one styli so that more than one line is made on the chart. The use of a magnetic tape recording allows the doctor to select to either simultaneously or individually play back both signals. Thus he can create a chart with chart lines showing the signals from both strain gauges or a chart of the signals independently and therefore the present invention provides for greater versatility. Further when the styli are used to record the signals simultaneously a problem can occur if something goes wrong with one styli and not the other and once again the test would have to be rerun. It is clear that the use of a magnetic tape recording as opposed to chart recording during a penile tumescence monitoring test ensures that the test results will be more reliably recorded and thus reduces the possibility of having the patient undergo the strain and embarrassment of another penile tumescence test.
Examples of other possible prior art devices and processes are shown in the following patents: U.S. Pat. No. 3,417,743, issued to Carrera on Dec. 24, 1968; U.S. Pat. No. 2,976,865, issued to Shipley on Mar. 28, 1961; U.S. Pat. No. 3,986,254, issued to Nordstrom on Oct. 19, 1976; U.S. Pat. No. 4,173,971, issued to Karz on Nov. 13, 1979; U.S. Pat. No. 3,461,863, issued to Sullinger on Aug. 19, 1969; U.S. Pat. No. 4,183,354, issued to Sibley et al. on Jan. 15, 1980; U.S. Pat. No. 3,845,760, issued to Birman on Nov. 5, 1974; U.S. Pat. No. 3,773,040, issued to Gavrilovich on Nov. 20, 1973 and U.S. Pat. No. 3,900,023, issued to McBride on Aug. 19, 1975.
The Carrera patent discloses an apparatus that is shaped to fit over the male penis. The apparatus has a plurality of pressure sensing devices and recording equipment. It is clear however that the device is used for enhancing sexual performance during sexual intercourse as opposed to penile tumescence monitoring. The Shipley patent discloses a cylindrical strain gauge while the Nordstrom patent shows an encased strain gauge. The Karz and Sibley patents relate to ambulatory electrocardiograph recorders. These patents and the others mentioned do not show any devices or systems which can be used for penile tumescence monitoring.